82 FR 45592 - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2018
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services Federal Register Volume 82, Issue 188 (September 29, 2017)
Centers for Medicare & Medicaid Services
Federal Register Volume 82, Issue 188 (September 29, 2017)
| Page Range | 45592-45593 | |
| FR Document | 2017-20883 |
[Federal Register Volume 82, Number 188 (Friday, September 29, 2017)] [Notices] [Pages 45592-45593] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-20883] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS-4181-N] Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2018 AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2018. The calendar year 2018 AIC threshold amounts are $160 for ALJ hearings and $1,600 for judicial review. DATES: This notice is applicable on January 1, 2018. FOR FURTHER INFORMATION CONTACT: Liz Hosna ([email protected]), (410) 786-4993. SUPPLEMENTARY INFORMATION: I. Background Section 1869(b)(1)(E) of the Social Security Act (the Act), as amended by section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review at $100 and $1,000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), amended section 1869(b)(1)(E) of the Act to require the AIC threshold amounts for ALJ hearings and judicial review to be adjusted annually. The AIC threshold amounts are to be adjusted, as of January 2005, by the percentage increase in the medical care component of the consumer price index (CPI) for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C/Medicare Advantage (MA) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals. A. Medicare Part A and Part B Appeals The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Act, is included in the applicable implementing regulations, 42 CFR 405.1006(b) and (c). The regulations require the Secretary of the Department of Health and Human Services (the Secretary) to publish changes to the AIC threshold amounts in the Federal Register (Sec. 405.1006(b)(2)). In order to be entitled to a hearing before an ALJ, a party to a proceeding must meet the AIC requirements at Sec. 405.1006(b). Similarly, a party must meet the AIC requirements at Sec. 405.1006(c) at the time judicial review is requested for the court to have jurisdiction over the appeal (Sec. 405.1136(a)). B. Medicare Part C/MA Appeals Section 940(b)(2) of the MMA applies the AIC adjustment requirement to Medicare Part C appeals by amending section 1852(g)(5) of the Act. The implementing regulations for Medicare Part C appeals are found at 42 CFR 422, subpart M. Specifically, Sec. Sec. 422.600 and 422.612 discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 422.600 grants any party to the reconsideration, except the MA organization, who is dissatisfied with the reconsideration determination, a right to an ALJ hearing as long as the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary. Section 422.612 states, in part, that any party, including the MA organization, may request judicial review if the AIC meets the threshold requirement established annually by the Secretary. C. Health Maintenance Organizations, Competitive Medical Plans, and Health Care Prepayment Plans Section 1876(c)(5)(B) of the Act states that the annual adjustment to the AIC dollar amounts set forth in section 1869(b)(1)(E)(iii) of the Act applies to certain beneficiary appeals within the context of health maintenance organizations and competitive medical plans. The applicable implementing regulations for Medicare Part C appeals are set forth in 42 CFR 422, subpart M and apply to these appeals pursuant to 42 CFR 417.600(b). The Medicare Part C appeals rules also apply to health care prepayment plan appeals pursuant to 42 CFR 417.840. D. Medicare Part D (Prescription Drug Plan) Appeals The annually adjusted AIC threshold amounts for ALJ hearings and judicial review that apply to Medicare Parts A, B, and C appeals also apply to Medicare Part D appeals. Section 101 of the MMA added section 1860D-4(h)(1) of the Act regarding Part D appeals. This statutory provision requires a prescription drug plan sponsor to meet the requirements set forth in sections 1852(g)(4) and (g)(5) of the Act, in a similar manner as MA organizations. As noted previously, the annually adjusted AIC threshold requirement was added to section 1852(g)(5) of the Act by section 940(b)(2)(A) of the MMA. The implementing regulations for Medicare Part D appeals can be found at 42 CFR 423, subparts M and U. The regulations at Sec. 423.562(c) prescribe that, unless the Part D appeals rules provide otherwise, the Part C appeals rules (including the annually adjusted AIC threshold amount) apply to Part D appeals to the extent they are appropriate. More specifically, Sec. Sec. 423.1970 and 423.1976 of the Part D appeals rules discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 423.1970(a) grants a Part D enrollee, who is dissatisfied with the independent review entity (IRE) [[Page 45593]] reconsideration determination, a right to an ALJ hearing if the amount remaining in controversy after the IRE reconsideration meets the threshold amount established annually by the Secretary. Sections 423.1976(a) and (b) allow a Part D enrollee to request judicial review of an ALJ or Medicare Appeals Council decision if, in part, the AIC meets the threshold amount established annually by the Secretary. II. Provisions of the Notice--Annual AIC Adjustments A. AIC Adjustment Formula and AIC Adjustments As previously noted, section 940 of the MMA requires that the AIC threshold amounts be adjusted annually, beginning in January 2005, by the percentage increase in the medical care component of the CPI for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10. B. Calendar Year 2018 The AIC threshold amount for ALJ hearings will remain at $160 and the AIC threshold amount for judicial review will rise to $1,600 for CY 2018. These amounts are based on the 59.989 percent increase in the medical care component of the CPI, which was at 297.600 in July 2003 and rose to 476.130 in July 2017. The AIC threshold amount for ALJ hearings changes to $159.99 based on the 59.989 percent increase over the initial threshold amount of $100 established in 2003. In accordance with section 1869(b)(1)(E)(iii) of the Act, the adjusted threshold amounts are rounded to the nearest multiple of $10. Therefore, the CY 2018 AIC threshold amount for ALJ hearings is $160.00. The AIC threshold amount for judicial review changes to $1,599.89 based on the 59.989 percent increase over the initial threshold amount of $1,000. This amount was rounded to the nearest multiple of $10, resulting in the CY 2018 AIC threshold amount of $1,600.00 for judicial review. C. Summary Table of Adjustments in the AIC Threshold Amounts In the following table we list the CYs 2014 through 2018 threshold amounts. ---------------------------------------------------------------------------------------------------------------- CY 2014 CY 2015 CY 2016 CY 2017 CY 2018 ---------------------------------------------------------------------------------------------------------------- ALJ Hearing.................................... $140 $150 $150 $160 $160 Judicial Review................................ 1,430 1,460 1,500 1,560 1,600 ---------------------------------------------------------------------------------------------------------------- III. Collection of Information Requirements This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). Dated: September 12, 2017. Seema Verma, Administrator, Centers for Medicare & Medicaid Services. [FR Doc. 2017-20883 Filed 9-28-17; 8:45 am] BILLING CODE 4120-01-P
![45592 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices
III. Copies of the Charter Protection Act of 2000 (BIPA), amounts for ALJ hearings and judicial
To obtain a copy of the Panel’s established the amount in controversy review. Section 422.600 grants any party
Charter, we refer readers to our Web site (AIC) threshold amounts for to the reconsideration, except the MA
at https://www.cms.gov/Regulations- Administrative Law Judge (ALJ) organization, who is dissatisfied with
and-Guidance/Guidance/FACA/ hearings and judicial review at $100 and the reconsideration determination, a
AdvisoryPanelon $1,000, respectively, for Medicare Part right to an ALJ hearing as long as the
ClinicalDiagnosticLaboratoryTests.html. A and Part B appeals. Section 940 of the amount remaining in controversy after
Medicare Prescription Drug, reconsideration meets the threshold
IV. Collection of Information Improvement, and Modernization Act of requirement established annually by the
Requirements 2003 (MMA), amended section Secretary. Section 422.612 states, in
This document does not impose 1869(b)(1)(E) of the Act to require the part, that any party, including the MA
information collection requirements, AIC threshold amounts for ALJ hearings organization, may request judicial
that is, reporting, recordkeeping or and judicial review to be adjusted review if the AIC meets the threshold
third-party disclosure requirements. annually. The AIC threshold amounts requirement established annually by the
Consequently, there is no need for are to be adjusted, as of January 2005, Secretary.
review by the Office of Management and by the percentage increase in the
C. Health Maintenance Organizations,
Budget under the authority of the medical care component of the
Competitive Medical Plans, and Health
Paperwork Reduction Act of 1995 (44 consumer price index (CPI) for all urban
Care Prepayment Plans
U.S.C. 3501 et seq.) consumers (U.S. city average) for July
2003 to July of the year preceding the Section 1876(c)(5)(B) of the Act states
Dated: September 22, 2017. year involved and rounded to the that the annual adjustment to the AIC
Seema Verma, nearest multiple of $10. Section dollar amounts set forth in section
Administrator, Centers for Medicare & 940(b)(2) of the MMA provided 1869(b)(1)(E)(iii) of the Act applies to
Medicaid Services. conforming amendments to apply the certain beneficiary appeals within the
[FR Doc. 2017–20923 Filed 9–28–17; 8:45 am] AIC adjustment requirement to context of health maintenance
BILLING CODE 4120–01–P Medicare Part C/Medicare Advantage organizations and competitive medical
(MA) appeals and certain health plans. The applicable implementing
maintenance organization and regulations for Medicare Part C appeals
DEPARTMENT OF HEALTH AND competitive health plan appeals. Health are set forth in 42 CFR 422, subpart M
HUMAN SERVICES care prepayment plans are also subject and apply to these appeals pursuant to
to MA appeals rules, including the AIC 42 CFR 417.600(b). The Medicare Part C
Centers for Medicare & Medicaid adjustment requirement. Section 101 of appeals rules also apply to health care
Services the MMA provides for the application of prepayment plan appeals pursuant to 42
[CMS–4181–N] the AIC adjustment requirement to CFR 417.840.
Medicare Part D appeals. D. Medicare Part D (Prescription Drug
Medicare Program; Medicare Appeals; Plan) Appeals
A. Medicare Part A and Part B Appeals
Adjustment to the Amount in
Controversy Threshold Amounts for The statutory formula for the annual The annually adjusted AIC threshold
Calendar Year 2018 adjustment to the AIC threshold amounts for ALJ hearings and judicial
amounts for ALJ hearings and judicial review that apply to Medicare Parts A,
AGENCY: Centers for Medicare & review of Medicare Part A and Part B B, and C appeals also apply to Medicare
Medicaid Services (CMS), HHS. appeals, set forth at section Part D appeals. Section 101 of the MMA
ACTION: Notice. 1869(b)(1)(E) of the Act, is included in added section 1860D–4(h)(1) of the Act
the applicable implementing regarding Part D appeals. This statutory
SUMMARY: This notice announces the regulations, 42 CFR 405.1006(b) and (c). provision requires a prescription drug
annual adjustment in the amount in The regulations require the Secretary of plan sponsor to meet the requirements
controversy (AIC) threshold amounts for the Department of Health and Human set forth in sections 1852(g)(4) and (g)(5)
Administrative Law Judge (ALJ) Services (the Secretary) to publish of the Act, in a similar manner as MA
hearings and judicial review under the changes to the AIC threshold amounts organizations. As noted previously, the
Medicare appeals process. The in the Federal Register annually adjusted AIC threshold
adjustment to the AIC threshold (§ 405.1006(b)(2)). In order to be entitled requirement was added to section
amounts will be effective for requests to a hearing before an ALJ, a party to a 1852(g)(5) of the Act by section
for ALJ hearings and judicial review proceeding must meet the AIC 940(b)(2)(A) of the MMA. The
filed on or after January 1, 2018. The requirements at § 405.1006(b). Similarly, implementing regulations for Medicare
calendar year 2018 AIC threshold a party must meet the AIC requirements Part D appeals can be found at 42 CFR
amounts are $160 for ALJ hearings and at § 405.1006(c) at the time judicial 423, subparts M and U. The regulations
$1,600 for judicial review. review is requested for the court to have at § 423.562(c) prescribe that, unless the
DATES: This notice is applicable on jurisdiction over the appeal Part D appeals rules provide otherwise,
January 1, 2018. (§ 405.1136(a)). the Part C appeals rules (including the
FOR FURTHER INFORMATION CONTACT: Liz annually adjusted AIC threshold
B. Medicare Part C/MA Appeals
asabaliauskas on DSKBBXCHB2PROD with NOTICES
Hosna (Katherine.Hosna@cms.hhs.gov), amount) apply to Part D appeals to the
(410) 786–4993. Section 940(b)(2) of the MMA applies extent they are appropriate. More
SUPPLEMENTARY INFORMATION: the AIC adjustment requirement to specifically, §§ 423.1970 and 423.1976
Medicare Part C appeals by amending of the Part D appeals rules discuss the
I. Background section 1852(g)(5) of the Act. The AIC threshold amounts for ALJ hearings
Section 1869(b)(1)(E) of the Social implementing regulations for Medicare and judicial review.
Security Act (the Act), as amended by Part C appeals are found at 42 CFR 422, Section 423.1970(a) grants a Part D
section 521 of the Medicare, Medicaid, subpart M. Specifically, §§ 422.600 and enrollee, who is dissatisfied with the
and SCHIP Benefits Improvement and 422.612 discuss the AIC threshold independent review entity (IRE)
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00018 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45780/page/1.svg)
![Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45593
reconsideration determination, a right to annually, beginning in January 2005, by over the initial threshold amount of
an ALJ hearing if the amount remaining the percentage increase in the medical $100 established in 2003. In accordance
in controversy after the IRE care component of the CPI for all urban with section 1869(b)(1)(E)(iii) of the Act,
reconsideration meets the threshold consumers (U.S. city average) for July the adjusted threshold amounts are
amount established annually by the 2003 to July of the year preceding the rounded to the nearest multiple of $10.
Secretary. Sections 423.1976(a) and (b) year involved and rounded to the Therefore, the CY 2018 AIC threshold
allow a Part D enrollee to request nearest multiple of $10. amount for ALJ hearings is $160.00. The
judicial review of an ALJ or Medicare AIC threshold amount for judicial
B. Calendar Year 2018
Appeals Council decision if, in part, the review changes to $1,599.89 based on
AIC meets the threshold amount The AIC threshold amount for ALJ the 59.989 percent increase over the
established annually by the Secretary. hearings will remain at $160 and the initial threshold amount of $1,000. This
AIC threshold amount for judicial amount was rounded to the nearest
II. Provisions of the Notice—Annual review will rise to $1,600 for CY 2018. multiple of $10, resulting in the CY
AIC Adjustments These amounts are based on the 59.989 2018 AIC threshold amount of $1,600.00
A. AIC Adjustment Formula and AIC percent increase in the medical care for judicial review.
Adjustments component of the CPI, which was at
297.600 in July 2003 and rose to 476.130 C. Summary Table of Adjustments in
As previously noted, section 940 of in July 2017. The AIC threshold amount the AIC Threshold Amounts
the MMA requires that the AIC for ALJ hearings changes to $159.99 In the following table we list the CYs
threshold amounts be adjusted based on the 59.989 percent increase 2014 through 2018 threshold amounts.
CY 2014 CY 2015 CY 2016 CY 2017 CY 2018
ALJ Hearing ............................................................................................. $140 $150 $150 $160 $160
Judicial Review ........................................................................................ 1,430 1,460 1,500 1,560 1,600
III. Collection of Information purpose of this guidance is to assist posted to the docket unchanged.
Requirements sponsors in reproductive toxicity Because your comment will be made
This document does not impose assessments (mainly of embryo-fetal public, you are solely responsible for
information collection requirements, development) for oncology ensuring that your comment does not
that is, reporting, recordkeeping or pharmaceuticals and to provide include any confidential information
third-party disclosure requirements. recommendations for product labeling that you or a third party may not wish
Consequently, there is no need for on duration of contraception following to be posted, such as medical
review by the Office of Management and cessation of therapy to minimize information, your or anyone else’s
Budget under the authority of the potential risk to a developing embryo/ Social Security number, or confidential
Paperwork Reduction Act of 1995 (44 fetus. The guidance also clarifies FDA’s business information, such as a
U.S.C. 3501 et seq.). current thinking on when nonclinical manufacturing process. Please note that
studies for reproductive toxicology if you include your name, contact
Dated: September 12, 2017. assessment may not be needed (e.g., for information, or other information that
Seema Verma, pharmaceuticals intended for use in identifies you in the body of your
Administrator, Centers for Medicare & postmenopausal women only). The comments, that information will be
Medicaid Services. intended outcome of this guidance is to posted on https://www.regulations.gov/.
[FR Doc. 2017–20883 Filed 9–28–17; 8:45 am] provide for more consistent labeling for • If you want to submit a comment
BILLING CODE 4120–01–P oncology pharmaceuticals and to reduce with confidential information that you
the conduct of nonclinical studies that do not wish to be made available to the
are not informative on product use. public, submit the comment as a
DEPARTMENT OF HEALTH AND DATES: Although you can comment on written/paper submission and in the
HUMAN SERVICES any guidance at any time (see 21 CFR manner detailed (see ‘‘Written/Paper
10.115(g)(5)), to ensure that the Agency Submissions’’ and ‘‘Instructions’’).
Food and Drug Administration
considers your comment on this draft Written/Paper Submissions
[Docket No. FDA–2017–D–2165] guidance before it begins work on the
Submit written/paper submissions as
final version of the guidance, submit
Oncology Pharmaceuticals: follows:
either electronic or written comments • Mail/Hand delivery/Courier (for
Reproductive Toxicity Testing and on the draft guidance by November 28,
Labeling Recommendations; Draft written/paper submissions): Division of
2017. Dockets Management (HFA–305), Food
Guidance for Industry; Availability
ADDRESSES: You may submit comments and Drug Administration, 5630 Fishers
AGENCY: Food and Drug Administration, as follows: Lane, Rm. 1061, Rockville, MD 20852.
HHS.
Electronic Submissions • For written/paper comments
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ACTION: Notice of availability. submitted to the Division of Dockets
Submit electronic comments in the Management, FDA will post your
SUMMARY: The Food and Drug following way: comment, as well as any attachments,
Administration (FDA or Agency) is • Federal eRulemaking Portal: except for information submitted,
announcing the availability of a draft https://www.regulations.gov/. Follow marked and identified, as confidential,
guidance for industry entitled the instructions for submitting if submitted as detailed in
‘‘Oncology Pharmaceuticals: comments. Comments submitted ‘‘Instructions.’’
Reproductive Toxicity Testing and electronically, including attachments, to Instructions: All submissions received
Labeling Recommendations.’’ The https://www.regulations.gov/ will be must include the Docket No. FDA–
VerDate Sep<11>2014 18:50 Sep 28, 2017 Jkt 241001 PO 00000 Frm 00019 Fmt 4703 Sfmt 4703 E:\FR\FM\29SEN1.SGM 29SEN1](https://thefederalregister.org/doc/82_FR_45780/page/2.svg)
Document Created: 2017-09-29 03:26:39
Document Modified: 2017-09-29 03:26:39
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | This notice is applicable on January 1, 2018. | |
| Contact | Liz Hosna ([email protected]), (410) 786-4993. | |
| FR Citation | 82 FR 45592 |
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